BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1214123 · Received October 24, 2008

    Report

    Report Number
    3002158293-2008-00556
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    April 14, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR HAS BEEN COMPLETED. THE CAUSE OF THE MONITOR NOT STARTING UP WAS A FAULTY PLD (U300) ON THE COMPUTER/ANALOG PCA WITHIN THE MONITOR. U300 IS A DUAL N AND P CHANNEL MOSFET. THE ROOT CAUSE OF THE U300 FAILURE CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY A RANDOM COMPONENT FAILURE. THIS IS AN UNUSUAL EVENT. NO ADVERSE EVENT RESULTED FROM THE U300 FAILURE. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE DAUGHTER OF A MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HER FATHER'S MONITOR WAS NOT POWERING UP. SHE STATED THAT SHE TRIED BOTH BATTERY PACKS AND NEITHER WOULD WORK. SUPPORT SENT A PATIENT SERVICES REPRESENTATIVE (PSR) TO THE PATIENT TO REPLACE THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR